Methods and apparatus for determining fallopian tube occlusion

ABSTRACT

Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.

BACKGROUND OF THE INVENTION

1). Field of the Invention

The field of the invention relates to methods and apparatuses fordetermining fallopian tube occlusion.

2). Discussion of Related Art

Female sterilization prevents pregnancy by occluding or mechanicallyblocking the fallopian tubes. There are several different occlusiontechniques—tubes can be tied or “ligated,” blocked with mechanicaldevices such as clips or rings, or scarred closed with electric current.

In partial salpingectomy, the fallopian tubes are cut and tied withsuture material. The Pomeroy technique, a widely used version of partialsalpingectomy, involves tying a small loop of the tube and cutting offthe top segment of the loop.

Clips are used to block the fallopian tubes by clamping down and cuttingoff the blood supply to a portion of the tubes, causing a small amountof scarring or fibrosis that prevents fertilization from occurring. Thetwo most common clips are the Filshie clip, made of titanium, and theWolf clip (also known as the Hulka clip), made of plastic. Clips aresimple to use, but each type requires a special applicator.

Tubal rings, like clips, also block the tubes mechanically. A very smallloop of the fallopian tube is pulled through the stretched ring. Whenthe ring is released, it stops the blood supply to that small loop. Theresulting scarring blocks passage of the sperm or egg. The Yoon Ring,made of silicone, is widely used.

Electrocoagulation uses electric current to coagulate or burn a smallportion of each fallopian tube. Unipolar coagulation passes currentthrough the forceps applied on the tubes, and the current leaves awoman's body through an electrode placed under her thigh. In bipolarcoagulation, current enters and leaves a woman through two ends of theforceps.

Occlusion device applied transcervically such as the ESSURE® devicemanufactured by CONCEPTUS, INC. are also used to permanently block thefallopian tubes.

Hysterosalpingography (HSG) is a known method for determining whether afallopian tube has been successfully occluded. In HSG, the uterus ispressurized with a fluoroscopically visual fluid. A radiologistfluoroscopically monitors the fallopian tubes to see if the fluidescapes past the occluded portion. Fluid seen escaping and filling thefallopian tubes, for example near the ovaries would indicate that thefallopian tubes are not occluded and that the patient may still befertile. HSG is problematic in that it requires a radiologist to bepresent and also requires the use of specialized equipment. Thus HSGalso cannot be performed in a doctor's office.

SUMMARY OF THE DESCRIPTION

The invention includes in one embodiment a method to detect fallopiantube occlusion, including visually identifying the cornua of a fallopiantube through a transcervical approach, wherein the fallopian tube wassubjected to a procedure to attempt to occlude the fallopian tube,coupling a device to a cornua to fluidly separate the cornua from theremainder of the uterus, pressurizing the cornua, and monitoring thepressurization of the cornua to determine if the fallopian tube isoccluded.

The device may be coupled to the cornua by an inflatable member of thedevice.

The inflatable member may be coupled to the cornua by applying forceagainst the cornua.

The inflatable member may be coupled to the cornua by a applying avacuum between the inflatable member and the cornua.

The cornua may be inflated to a pressure greater than 500 mmHg.

The method may be used with no fluoroscopic visualization of theprocedure.

The inflatable member is configured to separate the first cornua and asecond cornua from the remainder of the uterus by occupying a uterinecavity.

The inflatable member has at least one first lumen that is configured topressurize the first cornua, the at least one first lumen extendingthrough the inflatable member to align with the first fallopian tube.

The inflatable member has at least one second lumen that is configuredto pressurize the second cornua. The at least one second lumen extendsthrough the inflatable member to align with a second fallopian tube andis capable of being activated simultaneously with the at least one firstlumen.

The invention includes in one embodiment a method to determine fallopiantube occlusion, comprising distending a uterus with a first fluid, theuterus including at least one fallopian tube and cornua of the fallopiantube, wherein the fallopian tube was subjected to a procedure to attemptto occlude the fallopian tube, visually identifying the cornua of afallopian tube through a transcervical approach, coupling a device tothe cornua to fluidly separate a sealed portion of the cornua from theremainder of the uterus, applying a vacuum to the sealed portion of thecornua to evacuate a first fluid in the sealed portion of the cornua,pressurizing the cornua with a second fluid, and monitoring the volumeof the cornua to determine if the fallopian tube is occluded.

The device may be coupled to the cornua by an inflatable member of thedevice.

The inflatable member may be coupled to the cornua by applying forceagainst the cornua.

The inflatable member may be coupled to the cornua by a applying avacuum between the inflatable member and the cornua.

The cornua may be inflated to a pressure greater than 500 mmHg.

The second fluid may be visually differentiated from the first fluid.

The method may additionally include visually confirming that the secondfluid does not leak into the first fluid past the device,

The first fluid removed from the cornua portion may be measured.

The fallopian tube may be determined to be permanently occluded by theimplanted occlusion device by determining if there is more of the secondfluid inserted in the evacuated portion of the cornua than of the firstfluid removed from the evacuated portion of the cornua.

The second fluid may be non-soluble with the first fluid.

The method may be used with no fluoroscopic visualization of theprocedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is further described by way of example(s) with referenceto the accompanying drawings, wherein:

FIG. 1 is a cross section of a uterus including a utero-tubal junctionand cornua, and a previously implanted fallopian tube occlusion device.

FIGS. 2A-2C show cross sections of a uterus including a utero-tubaljunction and cornua, and a previously implanted fallopian tube occlusiondevice and a method to determine if the fallopian tube is fullyoccluded.

FIGS. 3A and 3B show cross sections of a uterus including a utero-tubaljunction and cornua, and a previously implanted fallopian tube occlusiondevice and a method to determine if the fallopian tube is fullyoccluded.

FIGS. 4A-4C show cross sections of devices which may be used todetermine if a fallopian tube is fully occluded.

FIGS. 5A-5D show cross sections of a uterus including a utero-tubaljunction and cornua, and a method to determine if the fallopian tube isfully occluded, according to another embodiment.

FIGS. 6A and 6B show cross sections of a uterus including a utero-tubaljunction and cornua, and a method to determine if the fallopian tube isfully occluded, according to another embodiment.

FIG. 7 shows a pump for providing pressure, according to one embodiment.

FIGS. 8A and 8B show cross sections of various embodiments of deviceswhich may be used to determine if a fallopian tube is fully occluded.

FIGS. 9A-9D show catheter cross sections of various embodiments used todetermine if a fallopian tube is fully occluded.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a cross section 100 of an ostium or cornua 102 of a uterus.The ostium or cornua 102 is considered to be the flower like opening ofa fallopian tube and lies between the greater uterus and the utero-tubaljunction 104 (hereinafter, “UTJ”). A previously placed implant 106 isshown placed in the UTJ. The function of the implant is to serve as aplatform for encouraging tissue growth occlusion, as shown by thecross-hatched area. When the UTJ has been fully occluded by tissuegrowth, typically 3 months after implantation, the fallopian tube willno longer be viable for fertilization. The fallopian tube may also besealed by other known operations, such as partial salpingectomy,electro-cauterization, or clips or rings applied externally to thefallopian tube. The methods and apparatuses described herein applyequally to all forms of tubal ligation.

The implant 106 includes a proximal portion that extends into the ostiumor cornua 102. The proximal portion of the implant 106 serves as avisual indicator of the placement of the implant 106. Devices such asthe ESSURE® device manufactured by CONCEPTUS, INC. include tail likevisual indicators. Not all fallopian tube implants include suchindicators. Even with a visual indicator, which shows only positiveplacement, the device may not fully occlude the utero-tubal junction104.

FIG. 2A illustrates one embodiment of the invention for determiningwhether a fallopian tube is occluded. The fallopian tube shows apreviously placed occlusion device 106. A device 200 is shown coupled tothe ostium or cornua 102 of a uterus. The device 200 may be delivered tothe ostium or cornua 102 by a hysteroscope which is transcervicallyapproached through the vagina of the patient. The uterus is alsotypically distended with a working fluid, such as saline. The cornua 102is visually identified using an image provided by hysteroscope, whichmay also be coupled to a monitor.

As shown, the device 200 includes an a sealing member 210 to fluidlyseal and separate a portion of the ostium or cornua 102 from theremainder of the uterus to create a sealed region. The sealing member210 is preferably inflatable, although this is not a requirement of thisembodiment of the invention. Force is applied by the operator of thedevice 200 to seal the sealing member 210 against the ostium or cornua102. In one embodiment, the sealing member 210 has an inflated diameterof the cornua 102 so that a sealed region is created regardless of theexpansion and contractions of the cornua 102.

In one embodiment, the sealing member 210 includes a biocompatibleadhesive 212 capable of creating a seal between the sealing member 210and the endometrium of the uterus. In one embodiment, the biocompatibleadhesive 212 is located along an outer circumference of the sealingmember 210 between the sealing member 210 and endometrial layer. It isunderstood that the adhesive 212 may be strategically applied inspecific locations around the sealing member 210 circumference to ensurethe sealing member 210 engages with the endometrium. It is alsounderstood that the biocompatible adhesive 212 can be any known adhesivesuch as wet adhesives, synthetic, natural, bio-adhesives, hydrogels,resins or any other adhesive suitable for application in the uterus.

In one embodiment, the adhesive 212 is a temporary adhesive applicationand may remove a portion of the endometrium upon removal of the sealingmember 210. However, the adhesive 212 should not cause the removal ofany portion of the myometrium upon removal of the sealing member 210.

FIG. 2B shows the device 200 applying a positive pressure through lumen210, as shown by the “+” marks, within a sealed portion of the cornua102. A pressure monitor, such as a pressure gauge, is also coupled tothe lumen 210. Pressure is applied for a set amount of time, for example30 seconds to 3 minutes, to determine if the sealed portion will holdpressure. If the sealed portion is able to maintain a desired amount ofpressure for a predetermined amount of time, one may be able topositively determine whether the fallopian tube is fully occluded. Apressure drop will show that the fallopian tube is not fully occluded.

The amount of pressure applied must be large enough to determine whetherthe fallopian tube is positively occluded. The fallopian tube may alsobe naturally and temporarily blocked. Past tests have determined that asmuch as 500 mmHg is required to remove a temporary blockage from afallopian tube. In another embodiment, a minimum pressure is about 50mmHg while a maximum pressure is about 350 mmHg. In one embodiment, anideal range of pressure is about 90-120 mmHg. Care should be taken suchthat enough pressure is applied to the cornua 102 to determine whetherthe fallopian tube is positively occluded while preserving thetemporarily blocked fallopian tube. Pressures greater than 500 mmHg maybe applied in order to determine intentional fallopian tube occlusion,for example 700-2000 mmHg.

This method is advantageous over previous method of determining whethera fallopian tube is occluded by previously implanted occlusion devices.Previous methods required pressurization of the entire uterus with afluoroscopically visible fluid, known as Hysterosalpingography (HSG). Aradiologist monitored the fallopian tubes via an x-ray device todetermine if the fluoroscopically visible fluid leaks past thepreviously implanted occlusion devices. This prior art procedure iscostly, because it requires the presence of a radiologist andspecialized x-ray equipment. The current invention does not requirefluoroscopic visualization of the procedure, and may be performed with aless specialized environment, such as a doctor's office. The sealingmember 210 may also include an adhesive as previously described above.

FIG. 2C shows an alternative embodiment of a method for determiningwhether a fallopian tube is occluded. The fallopian tube shows apreviously placed occlusion device 106. A device 220 is shown coupled tothe ostium or cornua 102 of a uterus. The device 220 may be delivered tothe ostium or cornua 102 by a hysteroscope which is transcervicallyapproached through the vagina of the patient. The uterus is alsotypically distended with a working fluid, such as saline. The cornua isvisually identified using an image provided by hysteroscope, which mayalso be coupled to a monitor.

As shown, the device 220 includes an a sealing member 230 to fluidlyseal and separate a portion of the cornua from the remainder of theuterus. The sealing member 230 is preferably inflatable, although thisis not a requirement of this embodiment of the invention. The sealingmember 230 features sealing chambers 240 circumferentially surroundingthe sealing member 230. The sealing member may be defined by twoprominent sections of the sealing member 230. A vacuum is appliedthrough vacuum lumens 250 to positively seal the sealing member to thecornua 102. A vacuum source (not shown) as known to one commonly skilledin the art, such as a pump, is also coupled to the vacuum lumens 250.

FIG. 2C shows the device 200 applying a positive pressure through lumen260, as shown by the “+” marks, with in sealed portion of the cornua. Apressure monitor (not shown) as commonly known to ones skilled in theart, such as a pressure gauge, is also coupled to the lumen 260.Pressure is applied for a set amount of time, for example 30 seconds to3 minutes, to determine if the sealed portion will hold pressure. If thesealed portion is able to maintain a desired amount of pressure for apredetermined amount of time, one may be able to positively determinewhether the fallopian tube is fully occluded. A pressure drop will showthat the fallopian tube is not fully occluded.

This method is particularly advantageous because it allows an operatorremove his hands from device 220, while simultaneously maintaining apositive seal against the cornua. In one embodiment, a bio-adhesive 262may located on circumferential portions of the prominent sections of thesealing member 230 to ensure a sealed engagement between the sealingmember 230 and the endometrium.

FIG. 3A illustrates one embodiment of the invention for determiningwhether a fallopian tube is occluded. The fallopian tube shows apreviously placed occlusion device 106. A device 300 is shown coupled tothe cornua 102 of a uterus. The device 300 may be delivered to thecornua by a hysteroscope which is transcervically approached through thevagina of the patient. The uterus is also typically distended with aworking fluid, such as saline. The cornua is visually identified usingan image provided by hysteroscope, which may also be coupled to amonitor.

As shown, the device 300 includes a sealing member 310 to fluidly sealand separate a portion of the cornua from the remainder of the uterus.The sealing member 310 is preferably inflatable, although this is not arequirement of this embodiment invention. Force is applied by theoperator of the device 300 to seal the sealing member 310 against thecornua 102. Alternatively the device 300 may use a vacuum to seal thesealing member 310 against the cornua such as shown in FIG. 2C.

FIG. 3A shows the device 200 applying a negative pressure through afirst lumen 320, as shown by the “−” marks, within the sealed portion ofthe cornua. Distension fluid is then evacuated from the sealed portionand measured using a measuring device as known to one commonly skilledin the art, such as a marked syringe. The amount of fluid evacuated willtypically be small, for example 1 cc or less, given that the volume ofthe sealed cornua is small.

FIG. 3B shows a second lumen 330 supplying a second fluid to replace thedistension fluid. The second fluid is pressurized in a device asdescribed in FIGS. 2A-2C, however it is not necessary to monitor thepressure. The pressure may be mechanically set by a pressure source asknown to one commonly skilled in the art, such as a syringe or pumpcoupled to a lockable leur, which is in turn coupled to lumen 330.

The volume of the second fluid applied is measured to determine if it isgreater than the amount of distension fluid removed. If the volumes areequal or close, for example within 10%, then the fallopian tube isdetermined to be positively occluded by the occlusion device I.

If the volume of the second fluid is significantly greater than theamount removed, for example more than 20%, then the second fluid likelyleaked past the utero-tubal junction and occlusion device 106. Thus itfollows that the occlusion device is not fully occluding the utero-tubaljunction. The volume of the lumen 330 should be considered whencalculating the volume of the second fluid applied into the evacuatedportion of the cornua.

The second fluid may be visually differentiated from the distensionfluid, for example colored with a green dye. This aids in visuallydetermining if any leaks exist between the sealing member 310 andcornua. The second fluid may also be non-soluble along with thedistension fluid, for example bio-compatible vegetable or mineral oil.In that case, both the distension fluid and second fluid may be measuredusing the same container, e.g. a single syringe, without intermixingbetween the fluids.

This method is advantageous over previous method of determining whethera fallopian tube is occluded by previously implanted occlusion devices.Previous methods required pressurization of the entire uterus with afluoroscopically visible fluid, known as Hysterosalpingography (HSG).This embodiment does not require fluoroscopic visualization of theprocedure, and may be performed with a less specialized environment,such as a doctor's office.

FIG. 4A shows one embodiment of a catheter 400 for use in methodsdescribed herein. The catheter includes an inflatable member 410, and alumen 420 for pressurizing a cornua of a fallopian tube. The inflatablemember 410 may be characterized as a circular shaped balloon. Ballooncatheters, materials, and methods of construction are well known in theart, for example as shown in U.S. Patents: U.S. Pat. No. 5,522,961, U.S.Pat. No. 6,585,687, and U.S. Pat. No. 6,024,722, all of which arerespectively incorporated herein by reference in their respectiveentirety. Appropriate coupling devices, such as leurs (not shown) arecoupled to the proximal portion of the catheter 400 for adding suitablepressures or vacuums to inflatable member 440 and the remaining lumens.The catheter is of a suitable working length for use in a transcervicalenvironment, for example 400 mm.

In one embodiment, a back portion 482 of the inflatable member 410 is aconcave shape. In another embodiment, the back portion 484 of theinflatable member 410 is a convex shape. A specific concave or convexshape can be selected depending on the curvature of the cornua.

FIG. 4B shows one embodiment of a catheter 430 for use in methodsdescribed herein. The catheter includes an inflatable member 440, and alumen 450 for pressurizing a cornua of a fallopian tube. It isunderstood that the lumen 450 can also include a first and second lumen,as shown in FIG. 4C. The inflatable member 440, may be characterized asa circular shaped balloon with at least two prominent sections 440 a and440 b. A vacuum space exists between sections 440 a and 440 b forapplication of a vacuum by lumens 460 for sealing the inflatable memberto a cornua of a fallopian tube. Appropriate coupling devices, such asleurs (not shown) are coupled to the proximal portion of the catheter430 for adding suitable pressures or vacuums to inflatable member 440and the remaining lumens. The catheter is of a suitable working lengthfor use in a transcervical environment, for example 400 mm.

FIG. 4C shows one embodiment of a catheter 470, and a first 476 andsecond 478 lumen, similar to the embodiment shown in FIG. 3A. Again, theinflatable member 472 is characterized by a circular shape and twoprominent radial portions 472 a, 472 b extending in a perpendiculardirection transverse to the longitudinal axis of the first 476 andsecond lumen 478. The first 472 a and second 472 b prominent portionsform a circular vacuum space 474 which will engage the cornual wall, asalready described. A vacuum suction is created within the vacuum space474 through the vacuum lumen 480. The same fluid distension techniquecan be applied to the catheter 470 through the first 476 and second 478lumen, as already described in FIGS. 3A and 3B.

FIG. 5A shows an arrangement 500 having an outer catheter or sheath 502with a proximal end and a distal end being inserted into a uterus 510with previously occluded portions 514. The sheath 502 is made from amaterial such as stainless steel, Teflon, silicone, or other knownmaterials and may be flexible or rigid. In one embodiment, the sheath502 can have a length in a range of about 12 cm to about 25 cm and adiameter in a range of 0.4 cm to about 0.8 cm.

The sheath 502 contains two inner catheters 504. The two inner catheters504 are shown in a collapsed position within the outer sheath 502 withrespective balloon end portions 506 located near the distal end of thesheath 502. As shown, the balloon end portions 506 are not inflated whenlocated within the outer catheter or sheath 502.

In addition, an outer sheath balloon 508 is connected with the outersheath 502. The outer sheath balloon 508 remains in a deflatedconfiguration upon insertion of the outer sheath 502 into the cervix.

FIG. 5B shows the outer sheath 502 being inserted into the uterus sothat a distal portion of the outer sheath 502 is located near the fundusregion 512 of the uterus 510. The inner catheters 504 are exposed byeither advancing the inner catheters 504 or by retracting the outersheath 502. The balloon end portions 506 are in a deflated configurationwhen the inner catheters 504 are in a collapsed position. Upon reachinga desired position, FIG. 5B illustrates the outer sheath balloon 508being inflated to engage the walls of the cervical canal to create asealed upper region of the uterus 510. The engagement of the outersheath balloon 508 prevents unwanted movement during subsequentprocedures. The outer sheath balloon 508 is connected with a first airor fluid source 516 for inflating the outer sheath balloon 508. Thesheath 502 is also connected with a second air or fluid source 520 and avacuum source 526 as will be discussed in further detail.

FIG. 5C shows the inner catheters 504 being moved from a collapsedposition to an open and extended Y-shaped position. The first catheter504 a is movable to seal a first cornua 518 a and the second catheter504 b is movable to seal a second cornua 518 b. The inner catheters 504can be configured to create pressure within a respective cornua region518 according to any of the embodiments previously described. Moreover,the inner catheters 504 can be configured to apply a fluid distensiontechnique according to any of the embodiments already described.

FIG. 5C further shows a first balloon end portion 506 a being inflatedby the first air or fluid source 516. In one embodiment, the air orfluid source can be a single source that can selectively allow air orfluid to flow to the outer sheath balloon 508 or the end balloonportions 506 through the use of a valve (not shown). It is understoodthat, in one embodiment, the outer sheath balloon 508 may not benecessary and may be removed or inactivated. In another embodiment,separate air or fluid sources may be used. In one embodiment, a separateair or fluid source 520 is provided to apply pressure or fluiddistension to the cornua regions 518 a, 518 b through lumens within theinner catheters 504 as already described. In one embodiment, the airsource 520 is a hand pump with a gauge of pressure. In anotherembodiment, the fluid source 520 is a syringe.

In one embodiment, a spring mechanism 522 is biased to expand the innercatheters 504 to an open Y-position. A wire 524 is connected with thespring mechanism 522 to activate or retract the spring mechanism 522 sothat the inner catheters 504 can move from an open Y-position to aclosed collapsed position. In one embodiment, the user may pull on thewire 524 to cause the spring mechanism 522 to retract causing the innercatheters 504 to collapse. It is understood that a spring mechanism thatexpands upon pulling of the wire 524 may be provided.

FIG. 5D further shows an embodiment 528 similar to FIG. 5C. However, theend balloon portions 506 have a vacuum cavity as described in FIGS. 2C,4B, and 4C. The vacuum cavity engages the cornual walls and creates asealed region for determining whether a fallopian tube is patent aspreviously described. A vacuum is created within the vacuum cavitythrough a vacuum source 526 and lumens within the catheter as previouslydescribed. The vacuum source 526 can also be utilized to deflate theouter sheath balloon 508 and end balloon portions 506 to a collapsedposition for withdrawal from the uterus. A collapsed withdrawal positionwould be similar to the insertion configuration shown in FIG. 5A.

FIG. 6A shows another embodiment 600 where a catheter or sheath 602having similar dimensions as already described is inserted into theuterus 604 having occluded regions 614. The sheath 602 has a proximalend and a distal end. FIG. 6A further shows the proximal end of thecatheter including a uterine balloon 606 in a collapsed position. Anouter sheath balloon 608 is shown in a collapsed position located at amid-portion of the sheath 602. In a collapsed position, the uterusballoon 606 is inserted through the cervix and into the uterus towardthe fundus region. The uterine balloon 606 is connected with an air orfluid source 610 through a lumen of the catheter 602. The uterineballoon 606 is also connected with a vacuum source 612 through acatheter lumen. It is understood that the outer sheath balloon 608 maybe connected with the same air or fluid source 610 and vacuum source 612for selective inflation and collapse. In one embodiment, the outersheath balloon 608 may be inflated or collapsed independently from theuterine balloon 606.

FIG. 6B shows the same embodiment described in FIG. 6A when the uterineballoon 606 and outer sheath balloon 608 are expanded. It is understoodthat the outer sheath balloon 608 may be removed or inactive, accordingto one embodiment. However, as shown in FIG. 6B, the outer sheathballoon 608 is expanded to engage the cervical canal wall while theuterine balloon 606 fills the uterine cavity and engages with thecornual regions of the uterus 604. In one embodiment, the balloon 606may not conform or fill the entire uterine cavity but it is configuredto provide a full engagement with the cornual regions of the uteruswithout filling the entire uterine cavity.

The uterine balloon 606 has a triangular or heart-shaped configurationwhen inflated. The uterine cavity is expandable so that it may stretchor adjust to the inflated uterine balloon 606 so that two sealed regions620 a, 620 b are created. The sealed regions 620 a, 620 b created areair tight or fluid tight if the occluded areas 614 are not patent. Theuterine balloon 606 engages the fundus and the cornua of the uterus tocreate a sealed region. As mentioned, the uterine balloon 606 isinflatable with air, water, saline solution, or any other known fluid.

The uterine balloon 606 also includes a first tube 616 and a second tube618 within the inflated balloon 606. The first tube 616 extends from adistal end of the catheter 602 to an upper corner region of the uterineballoon 606 to align with the tubal ostia. The first tube 616 includes adistal opening into the first sealed region 620 a of the uterus 604. Thesecond tube 618 includes a distal opening into the second sealed region620 b of the uterus 604 to align with the tubal ostia. It is understoodthat the first 616 and second tubes 618 may remain flush with an outersurface of the uterine balloon 606 or may extend beyond the outersurface of the uterine balloon 606 protruding into the sealed regions620 a, 620 b. The first 616 and second tube 618 are coupled to lumenswithin the catheter 602, as will be described in further detail.

After the sealed regions 620 a, 620 b are created, a second air or fluidpressure source 622 creates a pressure within the first tube 616, secondtube 618, and sealed regions 620 a, 620 b. In one embodiment, a handpump provides the necessary pressure. In another embodiment,bio-adhesives (as previously described) may be strategically applied onthe outer surface of the uterine balloon 606 to ensure the balloon 606is engaged with the endometrium to create a sealed region.

FIG. 7 shows an exemplary hand pump 700 for providing a pressure to thesealed regions 620 a, 620 b. The hand pump 700 includes a pump handle702, a dial 704, a connecting piece 706, and a relief valve 708. Thepump handle 702 is made of an elastic material such as rubber orsilicone that compresses air when a user closes his or her grip. When auser releases his or her grip, the handle 702 returns to an initialuncompressed state. The dial 704 indicates to the user how much pressureis created within the sealed regions 620 a, 620 b. In one embodiment, aminimum pressure of 50 mmHg is provided or a maximum of 350 mmHg. Anideal pressure range is 90-120 mmHg to determine whether the fallopiantube is successfully occluded. A check valve 708 is connected with thehand pump 700 to allow excess pressure to escape when a predeterminedvalue is reached. For example, in one embodiment, the check valve can beconfigured to release pressure above 350 mmHg to opening a fallopiantube or dislodging an implant. Therefore, when the user squeezes thepump handle 702 when the dial is reading 350 mmHg, the check valvereleases any excess pressure. The connecting piece 706 is connected to acatheter 710. The catheter 710 can be of the same configuration and typeof any catheter described in this application. Of course, if a fallopiantube is patent, the dial 704 will indicate a pressure drop so the userwill know the regions 620 a, 620 b are not sealed. It is understood thatnegative or positive pressure can be applied by the hand pump 700 andthe pump may be an automatic pump, according to one embodiment.

FIG. 8A illustrates an exemplary embodiment of a uterine balloon 800similar to the one shown in FIG. 613. The first 802 and second 804 tubesare shown protruding slightly beyond an outer surface 806 of the uterineballoon 800. The inner wall 808 of the uterine balloon 800 defines aninflation cavity 810 where the air, water, saline, or other liquid fillsthe balloon 800 for inflation. The balloon 800 can be made from anelastic material such as silicone, latex, urethane, and other knownflexible polymers. In one embodiment, the uterine balloon 800 isslightly larger than a typical uterus size. In one embodiment, theballoon 800 has an inflated width dimension 812 of 1.6-3.0 cm dependingon the size of a patient's uterus. In another embodiment, the inflatedwidth dimension 812 is at least 3.0 cm to ensure the balloon seals andengages with the fundal width. In one embodiment, the balloon 800 has aninflated length dimension 814 of 5-8 cm. In another embodiment, theinflated length dimension 814 is at least 8 cm to ensure the balloonseals and engages the uterus length. In yet another embodiment, theballoon can have an inflated width in a range from about 3-4 cm, aheight in a range of about 5-7 cm, and a depth range of about 1-1.5 cm.A pressure of about 150-250 mmHg can be used to inflate the balloon.

As previously mentioned, the first 802 and second 804 tubes can beindividually connected with a pressure source 816 such as the hand pumpand gauge described in FIG. 7. The advantage of having an individualtube and gauge connection is that each fallopian tube can be verifiedindependently of the other fallopian tube. In one embodiment, adifferent pressure is provided in the first tube 802 and second tube 804so that the individual verification of each tube can be easily achieved.In one embodiment, more than one hand pump or gauge 816 can be connectedwith the balloon 800.

The first 802 and second 804 tubes can be made from a material includingnylon, Teflon, silicone, tygon, polyethylene, and any other knownflexible polymer. In one embodiment, the tubal openings can be in therange of about 0.1-0.3 cm.

FIG. 8B illustrates another embodiment of a uterine balloon 818 havingthe same shape and dimensions as described above. The uterine balloon818 includes a first pair of tubes 820 and a second pair of tubes 822extending from a distal end of the catheter 824 to a respective sealedregion in alignment with a tubal ostia. The first 820 and second pair oftubes 822 together form a Y-shape as previously described.

The first pair of tubes 820 include a first lumen 820 a and a secondlumen 820 b. As described in FIG. 3A, a negative pressure is appliedthrough the first lumen 820 a within the sealed portion of the cornua.Distension fluid is evacuated from the sealed portion and measured usinga measuring device 826 such as a marked syringe. It is understood that aseparate syringe may be provided for each individual lumen or the samesingle syringe may be movable between each lumen. Again, a small amountof fluid can be evacuated such as 1 cc or less.

The second lumen 820 b can supply a second fluid to replace thedistension fluid. The volume of the second fluid applied is measured todetermine if it is greater than the amount of distension fluid removed.As previously mentioned, if the volumes are equal or close (within 10%),the fallopian tube is determined to be positively occluded by theocclusion device.

On the other hand, if the volume of the second fluid is significantlygreater than the amount removed, the second fluid is assumed to haveleaked past the utero-tubal junction and occlusion device as previouslydescribed.

The second pair of tubes 822 include a first lumen 822 a for removingdistension fluid and a second lumen 822 b for replacing the fluid. Thesecond pair of tubes 822 operate in the exact same manner as describedabove with respect to the first pair of tubes 820.

FIGS. 9A-9D illustrate various catheter cross-sectional views that maybe implemented in any of the embodiments previously discussed. FIG. 9Aillustrates a catheter cross-section embodiment having a first lumen902, a second lumen 904 and a third lumen 906 within the outer sheath.In one embodiment, the first lumen 902 is used to deliver air, fluid,saline, or any gas or liquid to inflate an outer sheath balloon 508, 608or end balloon 506, 606. In addition, the first lumen 902 may be used toevacuate or vacuum the air or fluid. In one embodiment, the second 904and third 906 lumen can be connected to inner catheters 504, 616 or theinner catheters can be located within the second and third lumen.

FIG. 9B shows another embodiment 908 having a first lumen 910, a secondlumen 912, a third lumen 914, a fourth lumen 916, and a fifth lumen 918.Again, the first lumen 902 provides air or fluid to the balloons and mayalso evacuate or vacuum the air or fluid. The second 912 and third 914lumens operate to evacuate a distension fluid from respective catheters,as previously described. The fourth 916 and fifth 918 lumens allow areplacement fluid to be injected into a sealed region, as previouslydescribed.

FIG. 9C shows yet another cross-sectional embodiment 920 having a firstlumen 922, a second lumen 924, a third lumen 926, a fourth lumen 928, afifth lumen 930, a sixth lumen 932, and a seventh lumen 934. The firstlumen 922 acts primarily as a vacuum source while the second lumen 924operates to fill the outer sheath balloon with air or fluid. The thirdlumen 926 primarily operates to fill the end balloon portions or uterineballoon with air or fluid. The fourth lumen 928 and fifth lumen 930operate to vacuum or evacuate a distension fluid. The sixth 932 andseventh lumen 934 operate to inject a second fluid into the sealedregion as previously described.

FIG. 9D shows another embodiment 936 having a first lumen 938, a secondlumen 940, a third lumen 942, a fourth lumen 944, and a fifth lumen 946.The first 938, second 940, and third lumen 942 operate in the samemanner as the embodiment described in FIG. 9C. The fourth 944 and fifth946 lumen are provided to supply a monitoring pressure to the sealedregion to determine if a respective fallopian tube is patent. The fourthlumen 944 correlates to one sealed region and the fifth lumen 946correlates to a second sealed region of the cornua.

Although the lumens show are generally a circular shape, it isunderstood that the lumen passages can be a variety of cross-sectionalshapes including semi-circles, squares, rectangles and any other knownshape for delivering air or fluid to a cornua for determining whether afallopian tube is occluded.

A significant advantage of the embodiments of the present invention isthat the fallopian tubes can be tested for patency either individuallyor simultaneously. Having both cornual regions tested simultaneouslyresults in reduced testing time and minimizes patient discomfort.

While certain exemplary embodiments have been described and shown in theaccompanying drawings, it is to be understood that such embodiments aremerely illustrative and not restrictive of the current invention, andthat this invention is not restricted to the specific constructions andarrangements shown and described since modifications may occur to thoseordinarily skilled in the art.

What is claimed:
 1. A method to determine fallopian tube occlusion,comprising: distending a uterus with a first fluid, the uterus includingat least one fallopian tube and a first cornua of a first fallopiantube, wherein the first fallopian tube was subjected to a procedure toattempt to occlude the first fallopian tube; visually identifying thefirst cornua of the first fallopian tube through a transcervicalapproach; coupling a device to the first cornua to fluidly separate asealed portion of the first cornua from the remainder of the uterus;applying a vacuum to the sealed portion of the first cornua to evacuatethe first fluid in the sealed portion of the first cornua through one ofat least two first lumens; measuring a volume of the first fluidevacuated from the first cornua portion; pressurizing the sealed portionof the first cornua with a second fluid by applying the second fluidthrough one of the at least two first lumens; and measuring a volume ofthe second fluid within the sealed portion of the first cornua todetermine if the first fallopian tube is occluded, wherein the firstfallopian tube is determined to be occluded by an implanted occlusiondevice by determining if there is more volume of the second fluidinserted in the sealed portion of the first cornua than of the firstfluid removed from the sealed portion of the first cornua.
 2. The methodof claim 1, wherein the second fluid is not soluble with the firstfluid.
 3. The method of claim 1, wherein no fluoroscopic visualizationof the procedure occurs.
 4. The method of claim 1, wherein coupling thedevice to the first cornua comprises: inflating an inflatable member ofthe device to apply force against the first cornua, the inflatablemember having two prominent sections extending in a perpendiculardirection transverse to a longitudinal axis of the at least two firstlumens extending through the inflatable member to align with the firstfallopian tube, and a circular vacuum space formed between the twoprominent sections and surrounding the at least two first lumens; andapplying a vacuum to the circular vacuum space between the inflatablemember and the first cornua.
 5. The method of claim 1, wherein the firstfallopian tube is determined to be occluded by the implanted occlusiondevice if the volume of the second fluid inserted in the sealed portionof the first cornua than is within 10% of the volume of the first fluidremoved from the sealed portion of the first cornua.
 6. A method todetermine fallopian tube occlusion, comprising: distending a uterus witha first fluid, the uterus including at least one fallopian tube and afirst cornua of a first fallopian tube; coupling a device to the firstcornua to fluidly separate a sealed portion of the first cornua from theremainder of the distended uterus; applying a vacuum to the sealedportion of the first cornua to evacuate the first fluid in the sealedportion of the first cornua; measuring a volume of the first fluidevacuated from the sealed portion of the first cornua; supplying asecond fluid to the sealed portion of the first cornua; measuring avolume of the second fluid supplied to the sealed portion of the firstcornua; and comparing the volume of the first fluid evacuated from thesealed portion of the first conua to the volume of the second fluidsupplied to the sealed portion of the first cornua to determine if thefirst fallopian tube is occluded.
 7. The method of claim 6, wherein thefirst fallopian tube is determined to be occluded if the volume of thesecond fluid inserted in the sealed portion of the first cornua iswithin 10% of the volume of the first fluid removed from the sealedportion of the first cornua.
 8. The method of claim 6, wherein measuringthe volume of the first fluid evacuated from the first cornua portioncomprises measuring with a marked syringe.
 9. The method of claim 6,wherein measuring the volume of the first fluid evacuated from the firstcornua portion comprises measuring 1cc or less.
 10. The method of claim6, additionally comprising visually confirming that the second fluiddoes not leak into the first fluid past the device.